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Liver-Cancer Detection Test Gets Breakthrough Device Status
Laboratory for Advanced Medicine (LAM) has received an FDA breakthrough device designation for its liver cancer detection test. The liquid biopsy blood test is designed to detect liver cancer––as early as Stage I––with high specificity and sensitivity.
Previously, LAM reported data from the preliminary clinical study of its cfDNA methylation-based biomarkers for the non-invasive detection of hepatocellular carcinoma (HCC) demonstrating 95% sensitivity and 97.5% specificity.
The new liver cancer detection test has a low false negative and false positive rate. Over 700,000 patients are at increased risk for liver cancer in the United States, and there is a 15-fold increase in five-year survival rates when the cancer is detected at early stages versus late stages.
Patients who have been diagnosed with liver cirrhosis and who are currently recommended for hepatocellular carcinoma (HCC) screening every six months by ultrasound are being enrolled in the multi-site, prospective study IvyGene Liver Cancer Test (CLiMB; Clinical Trials ID: NCT03694600) during a routine HCC screening visit. At the same clinical visit as their ultrasound, blood samples are taken for the liver cancer test and to determine the concentration of blood analytes.
The anticipated study duration for most subjects is approximately one month to complete one round of HCC screening using the liver cancer test, ultrasound, and diagnostic imaging.
LAM’s pipeline includes tests for the early detection of breast cancer, colorectal cancer, lung cancer, and nasopharyngeal carcinoma (NPC). The company’s researchers are also working to discover highly accurate biomarkers for brain, ovarian, and pancreatic cancers.
Source: BioSpace, September 3, 2019